Pharmaceutical Development Series - 2: Preclinical Development Handbook

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This resource provides a clear, step-by-step guide for successfully navigating preclinical drug development. It serves as a comprehensive reference for prioritizing and optimizing leads, assessing toxicity, pharmacogenomics, modeling, and understanding regulations. The book discusses essential considerations and offers detailed instructions on current methods and techniques. Each chapter is authored by leading experts across various disciplines in preclinical toxicology, equipping readers with the tools to adopt a multidisciplinary approach. The editor, with over thirty years of experience in the pharmaceutical and biotechnology sectors, has meticulously reviewed each chapter for thoroughness and clarity. Key topics include in vitro mammalian cytogenetics tests, phototoxicity, carcinogenicity studies, pharmacogenomics in personalized medicine, bridging studies, and toxicogenomics and toxicoproteomics. Each chapter explores potential challenges and solutions while outlining the limitations of methods used to assess drug safety and efficacy during the preclinical phase. This hands-on guide is essential for pharmaceutical scientists engaged in preclinical testing, enabling them to conduct and document safety tests that fulfill FDA requirements prior to the initiation of clinical trials.